Abstract
The characteristics of each scoring balloon seem to be different because material or configuration of scoring element in each device is unique. The aim of this study is to clarify the difference of scoring effect among 3 different scoring devices. We prepared 3 different scoring devices [Wolverine™ Cutting Balloon™ (CB), ScoreFlex™ NC (SF), NSE Alpha™ (NSE), n = 5 respectively. Balloon diameter is 3 mm and 2 types of silicone tubes with different elasticity [140 kPa (tube S) and 576 kPa (tube H), respectively. Inner diameter is 3 mm]. We dilated each balloon in each silicone tube with nominal pressure (NP) and 20 atmosphere (HP) and took a picture using a micro CT. We measured penetration depth of all scoring elements into silicone tube wall and calculated their percentage using the following formula; penetration depth/original scoring element height × 100. We also observed the deformation of scoring element during balloon inflation in each device. Scoring element of CB cut deeper into both tubes significantly than SF and NSE at both pressure (40.5% vs 25.1% and 16.8% at NP and 86.1% vs 33.5% and 29.1% at HP in tube S, p < 0.01, respectively, 62.6% vs 33.5% and 17.0% at NP and 93.3% vs 45.1% and 36.5% at HP in tube H, p < 0.01, respectively). Although no deformation of scoring element was recognized in CB, some deformations were observed in 50% of NSE and 40% of SF (p = 0.0377). Scoring balloon with sharp and firmly fixed scoring elements like CB may show definite scoring effect.
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Abbreviations
- CB:
-
Cutting balloon
- DCB:
-
Drug coated balloon
- DES:
-
Drug eluting stent
- HP:
-
High pressure
- MFCT:
-
Micro focus computed tomography
- NP:
-
Nominal pressure
- NSE:
-
NSE Alpha
- PCI:
-
Percutaneous coronary intervention
- PD:
-
Penetration depth
- SF:
-
ScoreFlex NC
References
Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, et al. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010;23:240–8.
Shah CA, Pfau SE. Percutaneous left main coronary intervention: a review of plaque modification in left main percutaneous coronary intervention. J Clin Med. 2018;7:180.
Ozaki Y, Yamaguchi T, Suzuki T, Nakamura M, Kitayama M, Nishikawa H, et al. Impact of cutting balloon angioplasty (CBA) prior to bare metal stenting on restenosis—a prospective randomized multicenter trial comparing CBA with balloon angioplasty (BA) before Stenting (REDUCE III). Circ J. 2007;71:1–8.
Okura H, Hayase M, Shimodozono S, Kobayashi T, Sano K, Matsushita T, et al. Mechanisms of acute lumen gain following cutting balloon angioplasty in calcified and noncalcified lesions: an intravascular ultrasound study. Catheter Cardiovasc Interv. 2002;57:429–36.
Schmidt T, Hansen S, Meincke F, Frerker C, Kuck KH, Bergmann MW. Safety and efficacy of lesion preparation with the AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry. EuroIntervention. 2016;11:1346–54.
Tsuchikane E, Aizawa T, Tamai H, Igarashi Y, Kawajiri K, Ozawa N, et al. Pre-drug-eluting stent debulking of bifurcated coronary lesions. J Am Coll Cardiol. 2007;50:1941–5.
Ashida K, Hayase T, Shinmura T. Efficacy of lacrosse NSE using the “leopard-crawl” technique on severely calcified lesions. J Invasive Cardiol. 2013;25:555–64.
Kawase Y, Saito N, Watanabe S, Bao B, Yamamoto E, Watanabe H, et al. Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis. Cardiovasc Interv Ther. 2014;29:134–9.
Rathore S, Matsuo H, Terashima T, Kinoshita Y, Kimura M, Tsuchikane E, et al. Rotational atherectomy for fibro-calcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interv. 2010;75:919–27.
Shlofmitz E, Jeremias A, Shlofmitz R, Ali ZA. Lesion preparation with orbital atherectomy. Interv Cardiol. 2019;14:169–73.
Kanada Y. Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant. 2013;48:452–8.
Lee HS, Kang J, Park KW, Ki YJ, Chang M, Han JK, et al. Procedural optimization of drug-coated balloons in the treatment of coronary artery disease. Catheter Cardiovasc Interv. 2021. https://doi.org/10.1002/ccd.29492.
Kitani S, Igarashi Y, Tsuchikane E, Nakamura S, Seino Y, Habara M, et al. Efficacy of drug-coated balloon angioplasty after directional coronary atherectomy for coronary bifurcation lesions (DCA/DCB registry). Catheter Cardiovasc Interv. 2021;97:E614–23.
Khan AA, Murtaza G, Khalid MF, White CJ, Mamas MA, Mukherjee D, et al. Outcomes of rotational atherectomy versus orbital atherectomy for the treatment of heavily calcified coronary stenosis: a systematic review and meta-analysis. Catheter Cardiovasc Interv. 2020. https://doi.org/10.1002/ccd.29430.
Hayashi T, Tanaka Y, Shishido K, Yokota S, Moriyama N, Tobita K, et al. Wire bias, insufficient differential sanding, and orbital atherectomy-induced coronary pseudoaneurysm. Circ Cardiovasc Interv. 2018. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007003.
Jujo K, Saito K, Ishida I, Kim A, Suzuki Y, Furuki Y, et al. Intimal disruption affects drug-eluting bobalt-chromium stent expansion: a randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol. 2016;221:23–31.
de Costa Ribamar J Jr, Mintz GS, Carlier SG, Mehran R, Teirstein P, Sano K, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812–7.
Lee RT, Grodzinsky AJ, Frank EH, Kamm RD, Schoen FJ. Structure dependent dynamic mechanical behavior of fibrous caps from human atherosclerotic plaques. Circulation. 1991;83:1764–70.
Acknowledgements
We thank Ryota Ito and Keisuke Murakami (both from Department of Modern Mechanical Engineering, Graduate School of Creative Science and Engineering, Waseda University) for their valuable help in data acquisition.
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The Wolverine™ Cutting Balloon™ was supplied by Boston Scientific Japan and Lacrosse NSE Alpha™ was supplied by NIPRO and ScoreFlex™ NC was supplied by OrbusNeich Japan. Kinoshita Y has received speaker’s honoraria from TERUMO, KANEKA, ASAHI INTECC, Boston Scientific Japan, OrbusNeich Medical, Medtronic Japan and Abbott Vascular Japan. The other authors have no conflicts of interest to declare.
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Movie1-4: The dilation of calcified vessel model by various devices. These movies show the scenes of dilation by various devices in calcified vessel model (thickness=400µm). Movie 1 was performed by non-compliant balloon, by ScoreFlexTM NC (SF) in Movie 2, by Lacrosse NSE AlphaTM(NSE) in Movie 3, and by WolverineTM Cutting BalloonTM (CB) in Movie 4. It looks that calcium tube was dilated explosively in Movie 1 to Movie 3 and their images are very similar. On the other hand, clear crack was able to see before dilation completely in M4 (MP4 491 kb)
Supplementary file2 (MP4 738 kb)
Supplementary file3 (MP4 749 kb)
Supplementary file4 (MP4 739 kb)
Movie 5 and 6: The OCT image during the dilation of calcified vessel model by Lacrosse NSE AlphaTM(NSE) and WolverineTM Cutting BalloonTM (CB). These movies were recorded by placing and activating only imaging core of optical coherence tomography catheter in the wire lumen of catheter. In Movie 5, only 2 cleavages were recognized after explosive expansion of calcified tube by NSE even though there were 3 elements on it. In Movie 6, 3 cleavages were recognized clearly after gradual expansion of calcified vessel model by CB (MP4 803 kb)
Supplementary file6 (MP4 598 kb)
Movie 7: Deformation of scoring element in NSE. A scoring element at 11 o’clock turned over in 8 seconds after balloon inflation. Another scoring element at 3 o’clock also turned over in 13 seconds after balloon inflation (MP4 4512 kb)
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Kinoshita, Y., Iwasaki, K. & Suzuki, T. Verification of the differences of scoring effect in current scoring balloons. Cardiovasc Interv and Ther 37, 513–518 (2022). https://doi.org/10.1007/s12928-021-00807-1
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DOI: https://doi.org/10.1007/s12928-021-00807-1